Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT05785494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based Support for Family Caregivers of Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Preparedness for caregiving', 'timeFrame': 'At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)', 'description': 'Preparedness for caregiving scale (PCS)'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)', 'description': 'The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)'}, {'measure': 'Change in health', 'timeFrame': 'At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)', 'description': 'RAND- 36'}, {'measure': 'Change in Anxiety and Depression', 'timeFrame': 'At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)', 'description': 'The Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Change in pre-loss grief', 'timeFrame': 'At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)', 'description': 'Prolonged Grief-12'}, {'measure': 'Change in post-loss grief', 'timeFrame': 'At baseline (before intervention), change from baseline after 4-6 weeks (follow-up 1) and after 8-10 weeks (follow-up 2)', 'description': 'Prolonged Grief-13'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative care', 'Family caregiver', 'Web-based support', 'Intervention'], 'conditions': ['Family', 'End of Life', 'Cancer Metastatic', 'Chronic Illness']}, 'referencesModule': {'references': [{'pmid': '40219770', 'type': 'DERIVED', 'citation': 'Bauman C, Wallin V, Doveson S, Furst P, Hudson P, Kreicbergs U, Alvariza A. The family caregiver-targeted web-based intervention "narstaende.se" facilitated everyday life for couples facing life-threatening illness: A qualitative study. Palliat Med. 2025 May;39(5):574-583. doi: 10.1177/02692163251327893. Epub 2025 Apr 12.'}]}, 'descriptionModule': {'briefSummary': "For family caregivers of patients with advanced cancer, preparedness for caregiving is crucial for maintaining health and quality of life both during care and after the death of the patient. This project contributes to earlier research funded by the Swedish Cancer Society, about an intervention that was delivered by a multi-professional team and proved to be successful in promoting preparedness. However, such interventions are often costly and logistically challenging. In addition, the Covid-19 pandemic has further significantly raised the need for digital alternatives in healthcare. As a possible solution, an evidence-based intervention, narstaende.se, has been developed consisting of recorded videos of conversations between clinicians and family caregivers (actors), linked to informational texts and a moderated chat forum. The intervention was pilot tested during 2020 and 2021, exploring feasibility, content and family caregivers' experiences. As preliminary results are promising, the intervention is taken one step further and tested as a web-based intervention in a larger scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a family caregiver, over 18 years of age, to a person with life-threatening illness cared for in specialized home care.\n\nExclusion Criteria:\n\n* Not being able to communicate in Swedish'}, 'identificationModule': {'nctId': 'NCT05785494', 'briefTitle': 'Web-based Support for Family Caregivers of Patients With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ersta Sköndal University College'}, 'officialTitle': 'Web-based Support to Promote Preparedness for Caregiving Among Family Caregivers of Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'MarieCederschiöldUniversity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Access to web-site', 'interventionNames': ['Other: Narstaende.se']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}], 'interventions': [{'name': 'Narstaende.se', 'type': 'OTHER', 'description': 'Web-site with supportive information, videos and chat forum targeting family caregivers of patients with life-threatening illness.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100 61', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Marie Cederschiöld University', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ersta Sköndal University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anette Alvariza', 'investigatorAffiliation': 'Ersta Sköndal University College'}}}}